FDA.reportPublic FDA data

MILLENNIUM

Primary DI
00190776319618
Brand
MILLENNIUM
Company
Avalign Technologies, Inc.
Model
2-170406
Device description
Curette Knife,
Published
2023-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KTGKNIFE, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTGKnife, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776319618PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776319618001907763196181907763196180190776319618

GMDN Terms#

Term, Definition table
TermDefinition
Eye spud/needleA hand-held manual ophthalmic surgical instrument intended to be used to remove a foreign body/object embedded in or adhering to the surface of the eye globe. It is typically made of high-grade stainless steel, and designed with a fine handle in the centre of the instrument. At one end is a thin concave blade with a rounded nose (spud), and at the other end is a spearhead-shaped needle. The ophthalmologist uses these tips to remove the foreign body/object. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(877)289-1096product.questions@avalign.com

Regulatory Flags#

DUNS number
792528510
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776435479Millennium1-510489L2026-10-20
00190776435486Millennium1-FK177R2026-10-20
00190776435493Millennium72-5255006452026-10-20
00190776435509Millennium1-3910152026-10-20
00190776435516Millennium1-750750202026-10-20
00190776435523Millennium1-750750402026-10-20
00190776435530Millennium1-636012026-10-20
00190776435547Millennium72-5255540SL2026-10-20
00190776435554Millennium1-9356482026-10-20
00190776435561Millennium72-522056116202026-10-20
00190776435578Millennium1-225402L2026-10-20
00190776435585Millennium1-225402R2026-10-20
00190776435592Millennium1-6020222026-10-20
00190776435608Millennium1-6020172026-10-20
00190776436612Millenium85-630049412026-10-20
00190776436629Millenium85-110109462026-10-20
00190776436636Millenium85-520062822026-10-20
00190776436643Millenium85-520029442026-10-20
00190776436674Millenium85-420339012026-10-20
00190776436681Millenium85-520234622026-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776433512MillenniumAvalign Technologies, Inc.KTG2026-10-05
G141547374150Carnegie Surgical LLCCarnegie Surgical LLCKTG2026-09-30
04054462905621evonosevonos GmbH & Co. KGKTG2026-08-21
04054462905638evonosevonos GmbH & Co. KGKTG2026-08-21
04054462911509evonosevonos GmbH & Co. KGKTG2026-08-19
04054462911516evonosevonos GmbH & Co. KGKTG2026-08-19
04054462911523evonosevonos GmbH & Co. KGKTG2026-08-19
04054462911530evonosevonos GmbH & Co. KGKTG2026-08-19
04054462911547evonosevonos GmbH & Co. KGKTG2026-08-19
04054462911554evonosevonos GmbH & Co. KGKTG2026-08-19
04054462911561evonosevonos GmbH & Co. KGKTG2026-08-19
04054462911578evonosevonos GmbH & Co. KGKTG2026-08-19
04054462911974evonosevonos GmbH & Co. KGKTG2026-08-19
04054462917136evonosevonos GmbH & Co. KGKTG2026-08-19
00840183531058BR Surgical, LLCBR Surgical, LLCKTG2026-07-17
00757770676521Bausch + LombBausch & Lomb IncorporatedKTG2026-06-22
00810220800300Adler Instrument CompanyAdler, Inc.KTG2026-06-02
00840343727550Gen2SURGIX MEDICAL LLCKTG2026-04-22
00840343727314GEN2SURGIX MEDICAL LLCKTG2026-04-16
00840343727321GEN2SURGIX MEDICAL LLCKTG2026-04-16
00757770429301Bausch + LombBausch & Lomb IncorporatedKTG2026-02-04
04250381870433SeparatorSpiggle & Theis Medizintechnik GmbHKTG2025-09-19
04250676723192Sickle knifeSpiggle & Theis Medizintechnik GmbHKTG2025-09-15
04250676735072KnifeSpiggle & Theis Medizintechnik GmbHKTG2025-09-15
04250676718600Rosen round knifeSpiggle & Theis Medizintechnik GmbHKTG2025-09-12
04250676740595Teschner sickle knifeSpiggle & Theis Medizintechnik GmbHKTG2025-09-11
04250676741790Rosen round knifeSpiggle & Theis Medizintechnik GmbHKTG2025-09-11
00190776409371MillenniumAvalign Technologies, Inc.KTG2025-08-28
00190776409388MillenniumAvalign Technologies, Inc.KTG2025-08-28
00194613056377MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-08-01